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Completed

NCT Number: NCT02571075

Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea

The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.

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Key information

Conditions

Tonsillitis Infections Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

About this study

DESIGN:

Design type: Prospective, randomized control trial Sample

  • Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study.
  • Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects.
  • Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy
  • Anesthesiologist classification one to three

Exclusion criteria

  • Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months
  • Anesthesiologist classification four
  • Prior neck or throat surgery
  • Allergy to gold

Treatment and study plan

Auricular Acupuncture

Other

The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.

Other names: "Battlefield Acupuncture" BFA

Primary outcomes

  1. Pain Scores

    Time frame: 10 days after the procedure.

    Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not.

  2. The Morphine Equivalent of Opioid Use

    Time frame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.

    The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period.

Secondary outcomes

  1. Return to Diet

    Time frame: Within 10 days post operatively

    Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)

  2. Number of Participants With Nausea Post Operatively

    Time frame: 1-3 hours postoperativey

    It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.

  3. Number of Participants With Nausea Post Operatively

    Time frame: 1-3 hours post operatively

    It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults

Acronym: BFA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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